Osteomyelitis Multi-center Prospective Cohort Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Osteomyelitis of Lower Extremities. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Construction of a Multicenter Disease-Specific Database and Prospective Cohort for Osteomyelitis
Overview
To establish a prospective, multicenter, real-world cohort of patients with osteomyelitis, by systematically collecting and analyzing detailed treatment and follow-up data, in order to provide clinical evidence for the standardization of its treatment
Detailed description
Study Design： This is a prospective, multi-center, real-world clinical study. Subjects will be assigned to different treatment regimens based on their diagnosis and differential diagnosis.
Conservatively Treated Cohort: Patients with bone infection who do not meet the criteria for surgical intervention will receive conservative therapy, which includes intravenous (IV) and oral antibiotics.
Surgically Treated Cohort: Patients meeting the surgical indications will undergo a staged surgical protocol. The first stage involves debridement and implantation of antibiotic-impregnated bone cement. The need for auxiliary internal or external fixation will be determined based on the patient's condition. The second stage, performed 8 weeks after the first, focuses on repairing the bone defect.
All treatments will be conducted in accordance with current clinical practice guidelines. This study is purely observational; it will only monitor and collect data on changes in relevant parameters during the treatment process without interfering with any other clinical decisions.
Data Collection：
The following information will be recorded and collected:
1. Unique subject identifier and basic demographic information. 2. Baseline status and information prior to treatment. 3. Key information related to the surgery. 4. Post-operative follow-up information, including:
（1）Pain score (Visual Analog Scale, VAS) （2)Quality of life (Short Form-36, SF-36) (3)Self-Rating Anxiety Scale (SAS) score (4)Limb function score (Disabilities of the Arm, Shoulder and Hand / Lower Extremity Functional Scale, DASH/LEFS) (5)Range of motion of adjacent joints (6)Occurrence of complications.
Complications include:
1. Surgical incision complications (e.g., dehiscence, skin necrosis). 2. Pin tract infection. 3. Fixation failure or breakage. 4. Reduced joint range of motion. 5. Other discomforts deemed by the investigator to be related to the surgery.
Cohort Stratification:
To comprehensively describe the clinical characteristics and outcomes of bone infection, the study data will be stratified into cohorts based on the real-world treatment received by the patients. Patients will be categorized into cohorts according to the actual treatment modality they received, with each treatment type constituting a separate cohort. All cohort classifications will be performed after data collection is complete, based on predefined criteria, and will not involve proactive intervention by the investigators.
Primary outcome measures
- Infection control rate at week 8 after treat [Time frame: 8 weeks after operation]
Secondary outcome measures (5)
- Disability of Arm Shoulder and Hand Scale（DASH） [Time frame: Pre-treatment; At 8 weeks post-treatment; At 12 months post-treatment]
- The 36-Item Short Form Health Survey [Time frame: Pre-treatment; At 8 weeks post-treatment; At 12 months post-treatment]
- Self-Rating Anxiety Scale (SAS) [Time frame: Pre-treatment; At 8 weeks post-treatment; At 12 months post-treatment]
- Pain score (assessed by Visual Analogue Scale) [Time frame: Pre-treatment;At 2 weeks post-treatment; At 8 weeks post-treatment; At 12 months post-treatment]
- Lower Extremity Functional Scale [Time frame: Pre-treatment; At 8 weeks post-treatment; At 12 months post-treatment]
Eligibility criteria
Inclusion criteria
- Signed informed consent provided.
- Diagnosis of osteomyelitis confirmed by the site per guidelines (including definitive/suggestive criteria).
Exclusion criteria
- Patients who, in the opinion of the investigator, are unable to comply with the entire study procedure (including postoperative management and regular follow-up) due to psychiatric, cognitive, or behavioral disorders, or other objective reasons.
- Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The First Hospital Affiliated to Army Medical University — Chongqing
Identifiers
NCT: NCT07251374 · (A)KY2025236